The direct reporting of adverse drug reactions by patients is becoming an increasingly important topic for discussion in the world of pharmacovigilance. At this time, few countries accept consumer reports. We present an overview of experiences with consumer reporting in various countries of the world. The potential contribution of patient reports of adverse drug reactions is discussed, both in terms of their qualitative and quantitative contribution. The crucial question is one of whether patient reports will increase the number and quality of the reports submitted and/or lead to a more timely detection of signals of possible adverse reactions, thus contributing to an enhancement of the existing methods of drug safety monitoring. To date, the data available are insufficient to establish such added value.

Aims and methodsTo describe patients with decreased libido during use of a H MG-CoA-reductaseinhibitor, and to discuss causality and pharmacological hypotheses for this association by analysis of the adverse drug reactions (ADR) database of the Netherlands Pharmacovigilance Centre Lareb. ResultsEight patients were identified as having decreased libido during use of statins. In two of these cases testosterone levels were determined and appeared to be decreased. ConclusionDecreased libido is a probable adverse drug reaction of H MG-CoA-reductase-inhibitors and is reversible. The ADR may be caused by low serum testosterone levels, mainly due to intracellular cholesterol depletion.

Sir: A letter published in the Journal 1 described olanzapine's effect in decreasing cocaine cravings and preventing relapse. We report similar positive outcome in a dual-diagnosis patient after olanzapine use.Case report. Mr. A, a 46-year-old single, African American man with a history of schizoaffective disorder, bipolar type (DSM-IV criteria), was being treated with depot haloperidol 250 mg IM every month. He also met DSM-IV criteria for cocaine dependence. He had been to several addiction treatment programs, but relapsed often even while adhering to monthly depot haloperidol and other psychosocial treatments. He used about 2 g of cocaine per week, which often worsened paranoia and led to frequent hospitalizations. After his most recent hospitalization, he was transferred to our 28-day residential program. Here, he reported worsened drug use with depot haloperidol use. He agreed to try olanzapine instead.Depot haloperidol dose was tapered and discontinued, while olanzapine was started at 10 mg at bedtime and then increased to 15 mg at bedtime. Mr. A reported improvement in his symptoms but still experienced distracting auditory hallucinations in the morning. An additional 5 mg of olanzapine was added in the morning. These scheduled doses of olanzapine improved his psychoses and decreased anxiety and frequency of "using" dreams and persistent thoughts of using cocaine. When asked to describe his cravings before olanzapine, he reported 7 on a 10-point Likert scale. His cravings decreased to 2 after olanzapine use. On discharge, he was referred to a halfway house and individual, group, and self-help therapy with Alcoholics Anonymous. At last contact, Mr. A had adhered to his outpatient program and completed 6 months of sobriety.Typical antipsychotic medications reportedly do not impact substance use when prescribed to dual-diagnosis patients. Instead, reports suggest worsening drug abuse.2-4 This effect is probably mediated through strong dopamine-2 (D 2 ) receptor blockade in the nucleus accumbens, which, when stimulated by drugs or alcohol, causes the sensation of reward or experience of high.5 Since the atypical antipsychotics have relatively less D 2 blockade, their negative effects on the reward pathway in the nucleus accumbens may also be less. These effects would not, hypothetically, increase cravings for alcohol or drugs.5 Clozapine and quetiapine have reportedly shown decreased cravings and active substance use when prescribed for psychotic or bipolar disorders in dual-diagnosis patients. Littrell et al. 6 conducted a 12-month open-label trial of olanzapine in 30 patients with schizophrenia and substance dependence and found that 70% of their sample achieved sobriety by the end of the study.Olanzapine's potential in decreasing cravings and relapse is most likely multifactorial. Olanzapine decreases anxiety and depression and causes sedation. Because these feelings often trigger drug use, their reduction may decrease relapse potential. Olanzapine reportedly decreased cocaine use in animals as well.7 Per...

The forced switch caused an increase in reports resembling an early Weber effect rather than a decrease in safety of the newer formulation. However, our analysis cannot exclude differences in pharmacokinetic, pharmacodynamic or safety characteristics.

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